Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine
OMIC-CARD
1 other identifier
observational
1,200
1 country
6
Brief Summary
The objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major cardiovascular disease will be identified. Finally, the modification of these predictions will be evaluated based on the genetic profiles. The main hypothesis holds that the integration of metabolomics, genomic and nutritional information will serve to personalize the approach to cardiovascular disease, both in prevention and treatment, and that these tools, in turn, will be valid enough to be applied systematically and efficiently in the IMPaCT cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFebruary 3, 2023
January 1, 2023
1.4 years
January 23, 2023
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolomics
Human plasma and serum will be analysed to obtain chemical information of the different families of metabolites.
Baseline
Study Arms (2)
Control Group
Six hundred volunteers. This group has to be without any type of cardiovascular Disease.
Case Group
Six hundred volunteers. In this group, participants must present a diagnosis of ischemic heart disease at least 1 year but less than 5 years from recruitment
Eligibility Criteria
Six recruitment nodes were established, each one from a different Autonomous Community (Andalusia, Cantabria, The Balearic Islands, Madrid, Navarra, and the Basque Country), Comprising cardiologist and primary care clinicians. In each of the 6 nodes, 100 participants without ischemic heart disease (ICD) will be recruited for the control group and another 100 for the case group. The controls will be selected through the health Centers, The cases will be selected in CS and in Cardiology consultations of the National Health Service (NHS).
You may qualify if:
- Age between 50 - 79 years old
- Living in Spain for more than 2 years
- Fluent in Spanish
- Ability for answer all the study questionaries'
- Ability to validly grant informed consent
- Ability to move on one's own
- Not under palliative care due to serious illness, institutionalized population will not be recruited
- Not planning any change of address to another autonomous community within a year.
- Receive health care in National Health System. Officials or self-employed workers with health coverage exclusively in "Mutuas" that do not allow telematics access to health data will be excluded.
You may not qualify if:
- Chronic alcoholism or regular alcohol consumption \> 80 g/d
- BMI \>40 kg/m²
- Patient with cancer treatment two years before
- Patient with history of gastrectomy or intestinal resection. Patients with acute infection or inflammatory process (e.g. Pneumonia), may be included in the study three months after the infectious process.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
ibs.GRANADA
Granada, Andalusia, 18012, Spain
Instituto de Investigación Sanitaria
Vitoria-Gasteiz, Araba, 01009, Spain
Institut D' Investigació Sanitària Illes Balears
Palma de Mallorca, Balearic Islands, 07122, Spain
Universidad de Cantabria
Santander, Cantabria, 39011, Spain
Servicio Navarro de Salud Osasunbidea
Pamplona, Navarre, 31006, Spain
UAM
Madrid, 28029, Spain
Biospecimen
The Biospecimen sample for this study will be the blood draw of serum and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar Buil- Cosiales, Doctor
Servicio Navarro de Salud - Osasunbidea
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
January 31, 2023
Study Start
December 19, 2022
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
February 3, 2023
Record last verified: 2023-01